Tata Consultancy Services
OBS: Essa posição está disponível para candidatos de SÃO PAULO/SP e LONDRINA/PR.
Come to one of the biggest IT Services companies in the world! Here you can transform your career!
Why to join TCS? Here at TCS we believe that people make the difference, that’s why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.
We are looking for a SERM Physician.
In this role you will:
- Responsible for signal detection and evaluation activities for assigned products.
- Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
- Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
- Authors regulatory periodic reports (PSUR/DSUR/PBRER) and associated documentation globally according to the agreed process and timelines – reviews and contributes to production of program documents such as protocols and aggregate safety reports.
- Acts as a member of a process improvement initiative team within GCSP.
- Completes any post audit/inspection activities within the required timeline.
- Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of SERM physician.
- Supports safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
Mandatory Skills:
- Fluent English.
- Medical Doctor (physician) with relevant PV experience.
- Relevant experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
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What do we offer?
TCS Benefits – Brazil:
- Health insurance
- Dental Plan
- Life insurance
- Transportation vouchers
- Meal/Food Voucher
- Childcare assistance
- Gympass
- TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates
- Partnership with SESC
- Reimbursement of Certifications
- Free TCS Learning Portal – Online courses and live training
- International experience opportunity
- Discount Partnership with Universities and Language Schools
- Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire
- TCS Gems – Recognition for performance
- Xcelerate – Free Mentoring Career Platform
- Tata Consultancy Services is an equal opportunity employer, our commitment to diversity & inclusion drives our efforts to provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of any socio-economic background, race, color, national origin, religion, sex, gender identity/expression , age, marital status, disability, sexual orientation or any others. We encourage anyone interested to build a career in TCS to participate in our recruitment & selection process.
- At Tata Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects each person. Our motto is Inclusion without exception.
At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer!
<<<>>>>>
What do we offer?
TCS Benefits – Brazil:
- Health insurance
- Dental Plan
- Life insurance
- Transportation vouchers
- Meal/Food Voucher
- Childcare assistance
- Totalpass
- TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates
- Partnership with SESC
- Reimbursement of Certifications
- Free TCS Learning Portal – Online courses and live training
- International experience opportunity
- Discount Partnership with Universities and Language Schools
- Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire
- TCS Gems – Recognition for performance
- Xcelerate – Free Mentoring Career Platform
- Tata Consultancy Services is an equal opportunity employer, our commitment to diversity & inclusion drives our efforts to provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of any socio-economic background, race, color, national origin, religion, sex, gender identity/expression , age, marital status, disability, sexual orientation or any others. We encourage anyone interested to build a career in TCS to participate in our recruitment & selection process.
At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer!
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